Performance Evaluation for IVDR FAQ
April 16, 2024
What documents and resources are needed for performance evaluation requirements under IVDR?
What is involved in the performance evaluation process for IVDs under the IVDR?
We have the answers…
Category: FAQS
Orphan Medical Devices FAQ
April 16, 2024
What are Orphan Medical Devices?
How are they regulated?
How does EU MDR impact orphan medical devices?
We explain all…
Nonconformities for MDR submissions FAQ
April 16, 2024
What are common nonconformities identified under the EU MDR?
What does a Notified Body want from your Technical Documentation?
What can mitigate risks and ensure compliance?
We have these answers and much more…
Intended Purpose, Intended Use and Indications for Use FAQ
April 16, 2024
Why is the “Intended Purpose” important for medical devices under EU MDR?
What are the key differences between “Intended Use” and “Indications for Use” for medical devices?
What information should be included in statements regarding “Intended Purpose” or “Indications for Use”?
We explain the answers to these questions and lots more…
EU MDR Readiness FAQ
April 16, 2024
What steps should be taken to prepare for compliance with EU MDR
How do you formulate a project plan?
How do you review Technical Documentation structure for EU MDR or IVDR?
We have the answers to these questions and more…
Consultancies vs Agencies for Clinical Regulatory Affairs FAQ
April 12, 2024
What is the difference between consultancies and agencies for Clinical Regulatory Affairs?
Should you work with an external agency or a consultancy?
We explain all…
Systematic Literature Review (SLR) FAQ
April 5, 2024
Why do you need a systematic literature review?
What steps are involved?
What are some key reasons for non-conformances in literature reviews during audits?
We have the answers to these questions and more…
Quality Management System (QMS) FAQ
April 5, 2024
What is a Quality Management System (QMS)?
Why is it important?
How does it work?
We have the answers to the questions and more…
Claiming Equivalence FAQ
April 3, 2024
What is the difference between claiming equivalence under EU MDR compared to MDD?
What are the key requirements for demonstrating equivalence?
What can improve the process of demonstrating equivalence under the EU MDR?
We answers your questions and more…
Post CE mark FAQ
April 3, 2024
What do you need to do after obtaining a CE mark?
What is involved in updating Technical Documentation post-CE mark?
We answer these questions and more…
